PAMQuIP
GCP Research Study Document Checklist
Below is a list of common study documents, although it may not be all-inclusive. Please note that every
protocol can differ in applicable requirements, complexity and needs, so there may be additional
documents not listed. Similarly, some of the documents listed below may not apply or be useful to every
study. Check those documents that apply to your study, and note the location of the document if stored
in another location (e.g. electronic file).
IRB Documentation
Location
IRB Submission and Review Tracking Log
New Protocols
 Complete application
 IRB formal action letters (conditional approvals, deferrals) corresponding
PI responses and pertinent correspondence
 Final approval letter
 Final consent/assent form(s)
Continuing Reviews
 Complete application
 IRB formal action letters (conditional approvals, deferrals), corresponding
PI responses and pertinent correspondence
 Final approval letter
 Final consent/assent form(s)
Amendments
 Complete application
 IRB formal action letters (conditional approvals, deferrals), corresponding
PI responses and pertinent correspondence
 Final approval letter
 Final consent/assent form(s)
Unanticipated Problems/Event Reports (including Significant Deviations)
 Complete Report
 IRB response, corresponding PI Response and pertinent correspondence
 Final IRB Acknowledgment letter (& amended materials if applicable)
Unanticipated Problems/Events Tracking Log
Minor Deviation Reports and Exception Requests
 Complete Report
 IRB response, corresponding PI Response and pertinent correspondence
 Final IRB Acknowledgment letter (& amended materials if applicable)
Minor Deviation and Exceptions Tracking Log
Study Staff Logs and CVs (documentation of qualifications/training)
Location
Roles & Responsibilities Log
Staff Signature Log
Research Staff CVs and Qualifications
Training Documentation Log
PAMQuIP 2013 Version 1
Used with Permission, Children's Hospital Boston 2013
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PAMQuIP
GCP Research Study Document Checklist
Study Protocol
Location
Current, approved Study Protocol
Expired Study Protocol versions
versions:
Informed Consent and Assent Forms
Location
Current, approved Informed Consent/ Assent Forms (stamped copy)
Expired Informed Consent and Assent Forms
version(s):
Consent Revision Log
Standard Operating Procedures
Location
Standard Operating Procedures (SOPs)
SOPs
version(s):
Recruitment Materials
Location
Recruitment Materials (posters, letters, mailings, thank you’s, etc.)
Expired recruitment materials
version(s):
Recruitment Log
Reports: Data Safety Monitoring
Location
Data Safety Monitoring Plan (and committee)
Data Safety Monitoring Reports & Meeting Minutes/Correspondence
Reports: External Monitoring
Location
Monitoring Log (documentation of external sponsor/regulatory audit)
Monitoring/Audit Reports and/or Letters
Subject Tracking Documents: Screening & Enrollment
Location
Subject Screening Log
Subject Enrollment Log
Subject Identification code list (Key)
PAMQuIP 2013 Version 1
Used with Permission, Children's Hospital Boston 2013
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PAMQuIP
GCP Research Study Document Checklist
Subject Case Histories
Location
Signed informed consent/assent forms
Signed, dated and completed case report forms
Documentation of CRF corrections
Source documents
Case Report Forms and Study/Subject Documents
Location
Current Case Report Forms (CRFs) (blank)
expired CRFs
List of Source Documents
Study and Subject Documents (blank copy of data collection tools, etc.)
Laboratory Documentation
Location
Normal Value/Range(s)
Certification/Accreditation for Facilities
Lab Director’s CV
CLIA Certification
Certification of Analysis
For Investigational Drug and Device studies:
Regulatory Documentation (drug/device studies)
Location
FDA Form 1572 (all versions)
Drug, PI
FDA Form 1571 (all versions)
Drug, Sponsor
IDE Statement of Investigator’s Commitment
Device, Sponsor-PI
FDA Annual Reports
FDA Financial Disclosure Form(s)
Drug/Device Accountability Log
Research Pharmacy
 Shipping records
 Randomization Codes
Sample Label for Investigational Product
IRB Membership Roster
PAMQuIP 2013 Version 1
Used with Permission, Children's Hospital Boston 2013
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PAMQuIP
GCP Research Study Document Checklist
Investigational Brochure
Location
Current Investigational Brochures
Expired Investigational Brochures
Investigational Brochure updates
Investigator Agreement/Contract
Investigator Agreement
Confidentiality agreement b/w investigator & sponsor
Insurance or indemnification letter
Location
Grant Application, Reporting & Correspondence
Location
Grant Application
Sponsor Progress Reports
Relevant Correspondence
Other
Equipment and Supplies (receipt, calibration and maintenance logs)
Financial agreements (budget contracts)
PAMQuIP 2013 Version 1
Used with Permission, Children's Hospital Boston 2013
Location
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